The following data is part of a premarket notification filed by Hunan Handlike Minimally Invasive Surgery Co., Ltd with the FDA for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument.
Device ID | K171825 |
510k Number | K171825 |
Device Name: | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Hunan Handlike Minimally Invasive Surgery Co., Ltd A4, Lugu Yuyuan, #27, Wenxuan Rd High-tech Zone Changsha, CN |
Contact | Hu Hanhan |
Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-19 |
Decision Date | 2018-02-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EAI0818 | K171825 | 000 |
EAI0788 | K171825 | 000 |
EAI0787 | K171825 | 000 |
EAI0786 | K171825 | 000 |
EAI0785 | K171825 | 000 |
EAI0784 | K171825 | 000 |
EAI0783 | K171825 | 000 |
EAI0782 | K171825 | 000 |
EAI0781 | K171825 | 000 |
EAI0780 | K171825 | 000 |
EAI0779 | K171825 | 000 |
EAI0778 | K171825 | 000 |
EAI0792 | K171825 | 000 |
EAI0793 | K171825 | 000 |
EAI0794 | K171825 | 000 |
EAI0817 | K171825 | 000 |
EAI0816 | K171825 | 000 |
EAI0815 | K171825 | 000 |
EAI0814 | K171825 | 000 |
EAI0813 | K171825 | 000 |
EAI0812 | K171825 | 000 |
EAI0811 | K171825 | 000 |
EAI0810 | K171825 | 000 |
EAI0809 | K171825 | 000 |
EAI0808 | K171825 | 000 |
EAI0807 | K171825 | 000 |
EAI0777 | K171825 | 000 |